Continuation of BIOEN 3801. Initial designs will be prototyped before going through a design review. Design verification issues and improvements will then be solved in a redesign phase following a design process based on FDA-QSR. Projects will be team oriented and lead to increased project management skills. In addition, discussions on design considerations will continue. A final written design document and an oral presentation of the working prototype will culminate the class. Lecture: 1 hour and Lab: 3 hours + 3 hours arranged.

Required Texts:

FDA 21CFR820: Title 21--Food and Drugs, Subchapter H - Medical Devices, Part 820 Quality System Regulation (available on the web at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820&showFR=1)